Needle guide devices for mounting on imaging transducers or adaptors on imaging transducer, imaging transducers for mounting needle guide devices and adaptors for imaging transducers for mounting needle guide devices thereon

ABSTRACT

A needle guide device for releasable mounting on an imaging transducer or on an adaptor bracket on an imaging transducer is disclosed. The needle guide device includes a universal lockable mounting member which is configured for slidable releasable engagement with a coupling member on a specially constructed imaging transducer or on a conventional imaging transducer onto which a specially constructed adaptor is mounted. The needle guide device makes use of a slidable mounting member to cooperate with the coupling member. The needle guide device is adjustable to establish various selectable angular trajectories for a needle and has a low profile form factor to result in the creation of a minimal blind zone when mounted on the transducer and even if establishing a large angle for shallow needle penetration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) from U.S.Provisional Application Ser. No. 62/078,744, filed on Nov. 12, 2014,entitled Needle Guide Devices For Mounting On Imaging Transducers OrAdaptors On Imaging Transducer, Imaging Transducers For Mounting NeedleGuide Devices And Adaptors for Imaging Transducers for Mounting NeedleGuide Devices Thereon, and also claims priority under 35 U.S.C. § 119(e)from U.S. Provisional Application Ser. No. 62/160,776, filed on May 13,2015, entitled Needle Guide Devices For Mounting On Imaging TransducersOr Adaptors On Imaging Transducer, Imaging Transducers For MountingNeedle Guide Devices And Adaptors for Imaging Transducers for MountingNeedle Guide Devices Thereon, both of which applications are assigned tothe same assignee as this application and whose disclosures areincorporated by reference herein.

FIELD OF THE INVENTION

This invention relates generally to needle guides for medical imaginginstruments and more particularly to devices for guiding needles intoselected locations of a patient relative to a medical instrument imagingsensor.

SPECIFICATION Background of the Invention

Imaging instruments, such as ultrasound probes, have revolutionized themanner in which many important medical procedures are performed. Thesemedical instruments utilize substantially non-invasive imagingtechniques to explore and assess the condition of human tissue. As aresult of these non-invasive imaging techniques, diagnostic andtherapeutic protocols have been developed that allow many highlysuccessful and safe procedures to be performed with a minimum ofdisturbance to patients. For example, ultrasound probes have become anaccepted modality for exploring endocavities, e.g., the human digestiveand reproductive tracts, of humans and animals in order to conductroutine examinations, as well as to identify evidence of tumors. Inparticular, using ultrasound, these tumors can be located and assessed.In conjunction therewith it is frequently desirable and even essentialthat biopsy samples of the tissue or fluid of a suspected tumor beremoved for analysis. To that end, biopsy samples may be taken bycarefully directing a hand-held needle, such as a biopsy instrument,catheter, or other thin instrument (hereafter referred to collectivelyas “needle” or “needles”) into the body of a patient in order to removea tissue sample. It is normally desirable that the needle be guided to aspecific position within the body. Unfortunately, hand-held direction ofa needle is often inadequate, being both inaccurate and time consuming.Thus, various needle guide devices have been designed for use withultrasonic probes or other imaging transducers to assist in directingneedles during imaging analysis.

Examples of such devices are found in the following United StatesPublications and Patents: 2006/0129046 (Stevens et al.), 2007/0049822(Bunce et al.), 2012/0165679 (Orome et al.), Des. U.S. Pat. No. 424,693(Pruter), U.S. Pat. No. 4,469,106 (Harui), U.S. Pat. No. 4,576,175(Epstein), U.S. Pat. No. 4,899,756 (Sonek), U.S. Pat. No. 5,052,396(Wedel et al.), U.S. Pat. No. 5,076,279 (Arenson et al.), U.S. Pat. No.5,235,987 (Wolfe), U.S. Pat. No. 5,623,931 (Wung et al.), U.S. Pat. No.5,758,650 (Miller et al.), U.S. Pat. No. 5,924,992 (Park et al.), U.S.Pat. No. 5,941,889 (Cermak), U.S. Pat. No. 6,203,499 (Imling et al.),U.S. Pat. No. 6,292,614 (Pruter), U.S. Pat. No. 6,361,499 (Bates etal.), U.S. Pat. No. 6,368,280 (Cermak et al.), U.S. Pat. No. 6,379,307(Filly et al.), U.S. Pat. No. 6,485,426 (Sandhu), U.S. Pat. No.6,884,219 (Pruter), U.S. Pat. No. 7,022,082 (Sonek), U.S. Pat. No.7,087,024 (Pruter), U.S. Pat. No. 7,351,205 (Szczech et al.), U.S. Pat.No. 7,452,331 (Pruter), U.S. Pat. No. 7,588,541 (Floyd et al.), U.S.Pat. No. 7,635,336 (Pruter), U.S. Pat. No. 7,691,066 (Kosaku), U.S. Pat.No. 7,909,815 (Whitmore, III et al.) U.S. Pat. No. 7,926,776 (Cermak),U.S. Pat. No. 7,959,573 (Furia), U.S. Pat. No. 8,073,529 (Cermak etal.), U.S. Pat. No. 8,137,281 (Huang et al.), U.S. Pat. No. 8,216,149(Oonuki et al.), U.S. Pat. No. 8,401,617 (Whitmore, III et al.) and U.S.Pat. No. 8,430,889 (Zeng et al.).

Some of the needle guides disclosed in the aforementioned patents andsome commercially available needle guides are designed to be mounted onan ultrasonic probe or other imaging instrument that is itself enclosedwithin a sterile cover, such as a film. These covers serve to maintainthe ultrasound sensor in a sterile environment, while reducing thelikelihood of contamination between patients and also reduce the cost ofmedical procedures by minimizing sterilization costs.

Notwithstanding the existence of the many prior art needle guidescurrently available, a need exists for an improved needle guide that isdisposable and can be securely mounted on a transducer with a cover anddismounted therefrom and without breaching or otherwise degrading thetransducer's cover's integrity, with both of such actions beingaccomplished easily with minimal effort. A need also exists for a needleguide making use of a universal releasably securable locking feature toeither facilitate its direct releasable attachment to prior arttransducers by modifying their housings to include a common or universaltransducer locating feature or coupling to which the universalreleasably locking feature can be releasably secured or to facilitatethe indirect releasable attachment of the needle guide to an unmodifiedprior art transducer by the use of a specially constructed bracket oradapter including a common or universal transducer locating feature towhich the universal releasably locking feature can be releasablysecured.

It is commonly a preference of users of ultrasound transducers on whicha needle guide is mounted to be able to select a desired angledtrajectory path to enable the user to reach an internal site in thepatient's body that can be close to or far away from the transducer.That is typically achieved by using an adjustable angle needle guide ora fixed angle needle guide having a desired needle trajectory angle.When a prior art fixed angle needle guide is selected for the task ofshallow needle penetration or a prior art adjustable needle guide isadjusted for a shallow needle penetration, the needle trajectory anglewill be at a relatively large acute angle to the centerline of thetransducer to bring the needle path close to transducer's image plane.In so doing, prior art needle guides typically have some portion whichprojects a substantial distance laterally outward from the transducer toestablish that trajectory. That projecting portion creates a “blind”spot or zone by hiding or otherwise obscuring a portion of the patient'sbody from direct viewing by the user. Thus, a need also exists for aneedle guide device that can establish a trajectory angle close to theimage plane, without any portion of it projecting greatly outwardlaterally from the transducer to thereby minimize the size of any blindspot that could result. The subject invention also addresses that need.

Moreover, a need exists for an adjustable needle guide device that: (1)is configured to permit the user to change the trajectory angletrajectory of the needle after the needle guide has been mounted on thetransducer and also to change the trajectory angle of the needle whilethe needle is disposed within the needle guide; (2) is configured toenable the user to select desired predetermined needle trajectory anglescorresponding to guidelines overlaid on the ultrasound system; (3)permits the user to utilize a “free-hand” approach, i.e., to adjust theneedle trajectory angle to any desired angle, to maintaining the needlewithin the ultrasound image plane of the transducer; and (4) isconfigured to enable the user to change the trajectory angle at anytime, e.g., before introduction of the needle into the needle guidedevice or after the needle has been inserted therein. The subjectinvention also addresses those needs.

BRIEF SUMMARY OF THE INVENTION

In accordance with one aspect of this invention there is provided aneedle guide device configured for releasable mounting on an imagingtransducer or on an adaptor on an imaging transducer. The imagingtransducer or the adaptor each includes a coupling member comprising afirst portion. The needle guide device comprises a lockable mountingmember and a needle guide assembly. The needle guide assembly comprisesa body member and a needle holder. The needle holder is mounted on thebody member and comprises an elongated passageway for receipt of aneedle to establish the trajectory of the needle when the needle islocated therein. The lockable mounting member comprises a slidablemember having a second portion. One of the first portion and the secondportion comprises a projection, and the other of the first portion andthe second portion comprises a recess. The slidable member is configuredto be slidably coupled to the body member and slidable from an unlockedposition to a locked position and vice versa. The projection isconfigured for receipt in the recess to releasably secure the slidablemember to the imaging transducer or the adaptor when the slidable memberis in the locked position, thereby releasably mounting the needle guidedevice on the imaging transducer.

In accordance with another aspect of this invention the needle holder isadjustably mounted on the body member to enable the needle holder to beoriented to various selected orientations, e.g., from approximately 0°to approximately 40° degrees, with respect to the body member toestablish various angled trajectories for the needle.

In accordance with another aspect of this invention the needle holder isoriented at a predetermined fixed angle with respect to the body memberto establish a desired angled trajectory for the needle.

In accordance with another aspect of this invention, the slidable membercomprises a portion of a lockable mounting assembly. The lockablemounting assembly comprises a body member including a stop. The stop isconfigured to engage the slidable member when the slidable member is inthe locked position, whereupon the coupling member is held between thestop and the second portion of the slidable member.

In accordance with another aspect of this invention a needle guidedevice configured for mounting on an imaging transducer or on an adaptoron an imaging transducer is provided. The needle guide device comprisesa base member, a barrel member, a slide member and a needle holder. Theneedle holder is mounted on the barrel member and comprises an elongatedpassageway for receipt of a needle to establish the trajectory of theneedle when the needle is located therein. The barrel member ispivotably mounted on the base member. The slide member is slidable withrespect to the base member and coupled to the barrel member to pivot thebarrel member with respect to the base member to a first angularorientation when the slide member is slid to a first position, and topivot the barrel portion with respect to the base member to a secondangular orientation when the slide member is slid to a second position.The needle holder establishes a first angular trajectory for the needlewhen the barrel member is in the first angular orientation andestablishes a second angular trajectory for the needle when the barrelmember is in the second angular orientation. The second angulartrajectory is different than the first angular trajectory.

In accordance with another aspect of this invention the needle guideassembly comprises a base member, a needle holder subassembly and aslide member. The needle holder subassembly comprises a barrel memberand the needle holder. The needle holder is located in the barrel memberand comprises an elongated passageway for receipt of a needle toestablish the trajectory of the needle when the needle is locatedtherein. The barrel member is pivotably mounted on the base member. Theslide member is slidable with respect to the base member and coupled tothe barrel member to pivot the barrel member with respect to the basemember to a first angular orientation when the slide member is slid to afirst position, and to pivot the barrel portion with respect to the basemember to a second angular orientation when the slide member is slid toa second position. The needle holder establishes a first angulartrajectory for the needle when the barrel member is in the first angularorientation and establishes a second angular trajectory for the needlewhen the barrel member is in the second angular orientation. The secondangular trajectory is different than the first angular trajectory.

In accordance with another aspect of this invention the barrel membercomprises a cylindrical cavity having a central longitudinal axis andwherein the needle holder comprises an elongated cylindrical memberlocated within the cylindrical cavity and rotatable about the centrallongitudinal axis. The needle holder has a passageway extendingtherethrough parallel to the central longitudinal axis. The passagewayis configured for receipt of the needle therein to establish theneedle's trajectory. The barrel portion includes a slot in communicationwith the cylindrical cavity and extending parallel and to the centrallongitudinal axis. The needle holder comprises a slot in communicationwith the passageway. The needle holder is rotatable within thecylindrical cavity between a closed and open position, and vice versa.The slot in the needle holder is aligned with the slot in the barrelwhen the needle holder is rotated to the open position. When in the openposition a needle extending through the passageway can be removed fromthe needle holder laterally through the aligned slots and a needle canbe introduced into the passageway laterally through the aligned slots.The slots are unaligned when the needle holder is in the closedposition, whereupon a needle disposed in the passageway is held therein.

In accordance another aspect of this invention the barrel membercomprises a cylindrical cavity having a central longitudinal axis andwherein the needle holder comprises an elongated cylindrical memberlocated within the cylindrical cavity and rotatable about the centrallongitudinal axis. The needle holder has a passageway extendingtherethrough parallel to the central longitudinal axis. The passagewayis configured for receipt of the needle therein to establish theneedle's trajectory. The barrel portion includes a slot in communicationwith the cylindrical cavity and extending parallel and to the centrallongitudinal axis. The needle holder comprises a slot in communicationwith the passageway. The needle holder is rotatable within thecylindrical cavity between a closed and open position, and vice versa.The slot in the needle holder is aligned with the slot in the barrelwhen the needle holder is rotated to the open position. When in the openposition a needle extending through the passageway can be removed fromthe needle holder laterally through the aligned slots and a needle canbe introduced into the passageway laterally through the aligned slots.The slots are unaligned when the needle holder is in the closedposition, whereupon a needle disposed in the passageway is held therein.

In accordance with another aspect of this invention there is provided animaging transducer for providing a signal representing an image of aninternal portion of the body of a patient for visualization by a user ofthe imaging transducer. The imaging transducer has a housing comprisinga coupling member for enabling the releasable securement of a needleguide device thereto. The needle guide device comprises a lockablemounting member having a second portion. The coupling member comprises afirst portion. One of the first portion and the second portion comprisesa projection, and the other of the first portion and the second portioncomprises a recess. The lockable mounting member is slidable from anunlocked position to a locked position with respect to the needle guidedevice, and vice versa. The projection is configured for receipt in therecess to releasably secure the lockable mounting member to the couplingmember when the lockable mounting member is in the locked position,thereby releasably mounting the needle guide device on the imagingtransducer.

In accordance with another aspect of this invention there is provided anadaptor for mounting on an imaging transducer. The imaging transducer isconfigured for providing a signal representing an image of an internalportion of the body of a patient for visualization by a user of theimaging transducer. The adaptor has a housing comprising a couplingmember for enabling the releasable securement of a needle guide devicethereto. The needle guide device comprises a lockable mounting member.The lockable mounting member has a second portion. The coupling membercomprises a first portion. One of the first portion and the secondportion comprises a projection, and the other of the first portion andthe second portion comprises a recess. The lockable mounting member isslidable from an unlocked position to a locked position with respect tothe needle guide device, and vice versa. The projection is configuredfor receipt in the recess to releasably secure the lockable mountingmember to the coupling member when the lockable mounting member is inthe locked position, thereby releasably mounting the needle guide deviceon the adaptor.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an isometric view of one exemplary embodiment of a needleguide device constructed in accordance with this invention shown mountedon an imaging transducer, e.g., an ultrasound probe, with a conventionalcover interposed therebetween, and with the needle guide device beingconfigured to provide a needle trajectory angle that can be varied asdesired;

FIG. 2 is an enlarged isometric view of the needle guide device shown inFIG. 1, but without the needle shown therein;

FIG. 3 is an isometric view of the bottom portion of the imagingtransducer of FIG. 1 showing a coupling member serving as a locatingfeature for releasably mounting the needle guide on the transducer;

FIG. 4 is a top plan view of the coupling member of the imagingtransducer shown in FIG. 3;

FIG. 5 is an enlarged isometric view of a lockable mounting memberforming a portion of the needle guide device of FIGS. 1 and 2 shownadjacent the coupling member of the imaging transducer, to enable thelockable mounting member to be releasably secured thereto to releasablymount the needle guide device on the transducer;

FIG. 6 is an isometric view of the lockable mounting member shown inFIG. 5;

FIG. 7 is an isometric view of the lockable mounting member of FIG. 5,but taken from a different direction;

FIG. 8 is a reduced side elevation view of the needle guide device ofFIG. 1 shown on the transducer establishing a 0° angle trajectory forthe needle;

FIG. 9 is a side elevation view, similar to that of FIG. 8, but showingthe needle guide device of FIG. 1 establishing a 40° angle trajectoryfor the needle;

FIG. 10 is an exploded isometric view of the needle guide assembly shownin FIG. 2 taken from a front oblique angle;

FIG. 11 is an exploded isometric view of the needle guide assembly shownin FIG. 2 taken from a rear oblique angle;

FIG. 12 is an isometric view of the needle guide device, like that shownin FIG. 2, but with a component thereof in an open position to enable aneedle to be inserted laterally into the needle guide device or removedlaterally from the needle guide device;

FIG. 13 is an isometric view of the needle guide device of FIGS. 1 and 2shown mounted on an adaptor bracket constructed in accordance with oneaspect of this invention, with the adaptor bracket being mounted on aconventional imaging transducer, e.g., an ultrasound probe, with aconventional cover interposed therebetween (although not shown in thisfigure);

FIG. 14 is an isometric view of the adaptor bracket of FIG. 13 shownmounted on a conventional imaging transducer;

FIG. 15 is an enlarged isometric view of the bottom portion of theadaptor bracket of FIG. 14 showing a coupling member thereof whichserves as a locating feature for releasably mounting the needle guidedevice on the adaptor bracket and hence on the conventional imagingtransducer;

FIG. 16 is a top elevation view of the portion of the coupling member ofthe adaptor bracket shown in FIGS. 14 and 15;

FIG. 17 is a reduced isometric view of the adaptor bracket of FIG. 14but showing the opposite side thereof, i.e., the side opposite thecoupling member;

FIG. 18 is an isometric view of another exemplary embodiment of a needleguide device constructed in accordance with this invention shown mountedon an imaging transducer, e.g., an ultrasound probe, with a conventionalcover interposed therebetween, and with the needle guide device beingconfigured to provide a fixed predetermined needle trajectory angle;

FIG. 19 is a side elevation view of the needle guide shown in FIG. 18;

FIG. 20 is a reduced side elevation view of the needle guide device ofFIG. 18 shown on the transducer establishing a 0° angle trajectory forthe needle;

FIG. 21 is a side elevation view, similar to that of FIG. 20, butshowing the needle guide device of FIG. 18 establishing a 40° angletrajectory for the needle;

FIG. 22 is an exploded isometric view of the needle guide assembly shownin FIG. 18 taken from a front oblique angle;

FIG. 23 is an exploded isometric view of the needle guide assembly shownin FIG. 18 taken from the rear side thereof;

FIG. 24 is an isometric view of the needle guide device of FIG. 18, butwith a component thereof in an open position to enable a needle to beinserted laterally into the needle guide device or removed laterallyfrom the needle guide device;

FIG. 25 is an isometric view of an adaptor bracket constructed inaccordance with this invention shown mounted on a conventionaltransducer, e.g., an ultrasound probe, to enable a needle guide devicelike shown in FIG. 18 to be mounted thereon;

FIG. 26 is an isometric view of one exemplary embodiment of a needleguide device constructed in accordance with this invention shown mountedon an imaging transducer, e.g., an ultrasound probe, and with the needleguide device being configured to provide a needle trajectory angle thatcan be varied as desired, but which as shown has been adjusted toestablish a 3° angle of penetration the needle;

FIG. 27 is an isometric view similar to FIG. 26, but showing the needleguide device adjusted to establish a 40° angle of penetration for theneedle;

FIG. 28 is a slightly enlarged isometric view of the bottom portion ofthe imaging transducer of FIG. 26 showing a coupling member serving as alocating feature for releasably mounting the needle guide device on thetransducer;

FIG. 29 is a top plan view of the coupling member of the imagingtransducer taken along line 29-29 of FIG. 28;

FIG. 30 is a front elevation view of the coupling member shown in FIGS.28 and 29;

FIG. 31 is an enlarged front oblique isometric view showing the needleguide device of FIG. 26 about to be mounted on the imaging transducervia the coupling member shown in FIGS. 28-30;

FIG. 32 is an front oblique isometric view of a portion of the needleguide device of FIG. 31 for releasable securement to the coupling membershown in FIGS. 26-28 to releasably mount the needle guide device ontothe imaging transducer;

FIG. 33 is a rear oblique isometric view of the portion of the needleguide device shown in FIG. 32;

FIG. 34 is an enlarged exploded isometric view showing a portion of alockable mounting assembly forming a portion of the needle guide deviceof FIG. 26;

FIG. 35 is an isometric view similar to FIG. 34 but showing the lockablemounting member of the lockable mounting assembly disposed within acorresponding slot in the body member of the needle guide device;

FIG. 36A is a slightly enlarged elevation view of the locking leverforming a portion of the lockable mounting assembly shown in FIG. 34;

FIG. 36B is an isometric view of the locking lever shown in FIG. 36A;

FIG. 37 is a reduced side elevation view of the needle guide deviceshown in FIG. 26;

FIG. 38 is a reduced side elevation view of the needle guide deviceshown in FIG. 27;

FIG. 39 is an enlarged front oblique isometric view of the needle guidedevice shown in FIG. 31 but taken from a different angle to more clearlyshow the mechanism for adjusting the angle of penetration for a needlelocated within the needle guide device;

FIG. 40 is an exploded isometric view showing a portion of the mechanismfor adjusting the angle of penetration for a needle located within theneedle guide device;

FIG. 41 is an exploded isometric view of the needle guide device of FIG.26, but without the lockable mounting assembly;

FIG. 42 is an enlarged isometric view of a lock slide or lever forming aportion of the mechanism for adjusting the angle of penetration of aneedle located within the needle guide device;

FIG. 43 is a reduced isometric view of an adaptor constructed inaccordance with one aspect of this invention shown mounted on aconventional imaging transducer to enable a needle guide deviceconstructed in accordance with this invention to be able to be mountedthereon, and hence mounted on a conventional imaging transducer; and

FIG. 44 is an isometric view similar to FIG. 43, but showing theopposite side of the adaptor, i.e., the side opposite the couplingmember, mounted on the conventional imaging transducer shown in FIG. 43.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the various figures of the drawing wherein likereference characters refer to like parts, there is shown in FIG. 1 oneexemplary preferred embodiment of a reusable needle guide device 20constructed in accordance with this invention. Another preferredexemplary embodiment of a reusable needle guide device 20′ constructedin accordance with this invention is shown in FIG. 18. Still anotherreusable needle guide device 20″ constructed in accordance with thisinvention is shown in FIG. 21. Those three exemplary embodiments areconfigured to be releasably mounted directly on an imaging instrument,e.g., an ultrasound transducer or probe 10, or indirectly mounted on anadaptor bracket 200 constructed in accordance with this invention andshown in FIGS. 13 and 25, to guide a needle 12 or any other elongatedinstrument through a desired path or trajectory into the body of apatient (human or animal) for a tissue biopsy procedure or any number ofother medical procedures.

As will be seen and described in detail later the needle guide device 20is adjustable, so that it can establish a trajectory path enabling theneedle or instrument to reach an internal site in the patient's bodythat is close to or far away from the distal or working end of thetransducer. In particular, the needle guide device 20 is configured toenable the user to adjust the needle angle trajectory through a widerange, e.g., a range of approximately 40 degrees. The needle guidedevice 20′ of FIG. 18 and the needle guide device 20″ of FIG. 21 are notadjustable. Rather, each establishes a fixed, different respective,trajectory angle for the needle or other instrument. In accordance withone preferred aspect of this invention a plurality of fixed angle needleguide devices, like guides 20′ and 20″ can be provided in the form of akit of several fixed needle guide devices, each establishing its own,and different, angled trajectory path. Thus, by the appropriateselection of the fixed angle needle guide the user can establish thedesired angular path for the needle or other instrument.

Irrespective of whether the needle guide device is an adjustable angleor fixed angle device, all of the needle guide devices of this inventionmake use of a mounting feature to enable them to be readily and quicklymounted on an imaging transducer 10, with a conventional cover 14interposed therebetween. That cover is typically formed of a thin,flexible sheath of any suitable material, e.g., latex, into a suitableshape, e.g., condom-shaped sheath, to be placed over the imagingtransducer before the needle guide device is mounted thereon to keep thetransducer sanitary. In the interest of drawing simplicity the cover hasbeen omitted from many of the figures of the drawing, it beingunderstood that the cover is, in fact, interposed between the needleguide device and the imaging transducer on which the needle guide deviceis mounted or interposed between the needle guide device and the adaptorbracket on which the needle guide is mounted.

The releasably mounting feature of this invention will be described indetail later. Suffice it for now to state that the exemplary needleguide devices 20, 20′ and 20″ include a locking member that isconfigured to be slidably releasably secured to a locating feature orcoupling member that is provided on a specially constructed imagingtransducer housing or is provided on a bracket or adapter for use on aconventional imaging transducer. Moreover, the adjustable needle guidedevice 20 and the fixed needle guide device 20″ (and all other needleguides constructed in accordance with subject invention), enable theuser to establish a very shallow depth of penetration for a needle, witha minimal blind spot, since the needle guides do not include any portionwhich projects far out from the transducer to block the view of theuser, i.e., all of the needle guide devices of this invention have acompact form factor.

Turning now to FIGS. 1 and 2 it can be seen that the needle guide device20 basically comprises a needle guide assembly 22 and a lockablemounting member 24. The lockable mounting member is configured to bereleasably secured to a universal or common locating feature or couplingmember 16 that is located on the housing of the transducer adjacent thedistal or working end of the transducer. The coupling member 16 ispreferably mounted at the location of the typical “#1 array indicator”of a conventional ultrasonic transducer. As best seen in FIGS. 3-5 thecoupling member 16 is in the form of a projection of somewhatrectangular profile and having an enlarged top portion 16A and a pair ofundercut recesses 16B on the opposed long sides of the projection.

The lockable mounting member 24 is best seen in FIGS. 6 and 7 andbasically comprises a rectangularly shaped frame, e.g., an integrallymolded plastic component, having one side section in the form of athickened handle 26, a pair of intermediate sections 28 and 30 extendingfrom respective ends of the handle section and an opposite side section32 connected between the intermediate sections. A cross-piece section 34extends parallel and closely adjacent the handle section. The crosspiece includes a projection, e.g., a flange, 36 extending along thelength thereof. As best seen in FIG. 6, the sections 26, 28, 30 and 32define a window 38 therebetween. The window 38 is configured to receivethe transducer's coupling member 16 and the portion of the cover 14overlying the top 16A of the coupling member when the guide device 20 isto be mounted on the transducer. In particular, as will be described indetail later, the lockable mounting member 24 is configured to beslidably received within a slot or channel 62 (to be described later)forming a portion of the needle guide assembly 22 so that it can be slidby a user pushing on the handle from an open position wherein thecoupling member is located within the window 38, to a locked position,and vice versa. When the lockable mounting member is in the lockedposition the coupling member is still located within the window 38, butthe flanged projection 36 is disposed within the confronting undercutrecess 16B of the coupling member 16. This action releasable secures thelockable mounting member 24 to the transducer coupling member.

In order to ensure that the lockable mounting member is held in thelocked position so that it is resistant to accidental displacement, itincludes a pair of extending fingers 40 projecting outward from therespective ends of its side section 32. Each finger 40 is connected toits respective end of the side section 32 by a short flexible bridgesection 42, which engages a respective portion in the slot or channel 62of the needle guide assembly to securely hold the lockable mountingmember in the locked position. The bridge sections 42, being resilient,are effectively spring-biased so that they are configured to be flexedinward when the fingers 40 are squeezed together by a user. This bringsthe bridge sections 42 towards each other to thereby release thelockable mounting member 24 from its locked position. That actionenables the lockable mounting member to be slid to its open position,wherein the flanged projection 36 is outside of (beyond) the undercutrecess 16B of the coupling member and with the coupling member beingwithin the window 38 to effectively free the coupling member, therebydisconnecting the needle guide device from the imaging transducer. Ifdesired, the lockable mounting member can be removed from the needleguide by squeezing the fingers 40 together after the transducer'scoupling member 16 is out of the window 38 and then pulling on thehandle 36 to pull the lockable mounting member out of the slot orchannel 62.

Referring now to FIGS. 2, 10 and 11 the details of the needle guideassembly 22 will now be described. To that end, it basically comprises abody or base member 44, a needle holder subassembly 46 and a slidemember 48. Each is molded of a suitable plastic material. The bodymember 44 comprises a generally flat panel having a pair of long sides50A and 50B. A pair of triangularly shaped flanged ears 52A and 52Bproject rearwardly from the bottom portions of the sides 50A and 50B,respectively. Each ear includes a short slot terminating in a circularhole 54 for accommodating a respective pivot pin of a cylindricallyshaped barrel member 56 (to be described shortly) forming a portion ofthe needle holder subassembly 46. The holes 54 are axially aligned. Agenerally planar back wall 58 extends between the marginal edges of thetriangular ears as best seen in FIG. 9. The front portion of the bodymember 44 includes an arcuate recess or cavity 60, as best seen in FIG.8, which is configured to accommodate the barrel member 56. The backwall 58 includes a slot or channel 62 extending from one side of theback wall to the other and is open to the back surface of the back wallfrom the ear 52A to a point adjacent the ear 52B. A central opening 64is located in the front surface of the back wall and is shaped toaccommodate the top portion 16A of the transducer coupling member 16 toreleasably secure the needle guide device to the transducer.

The barrel member 56 is an elongated generally tubular member having acentrally located front slot 66 extending parallel to the centrallongitudinal axis 78 of the barrel member. A pair of triangular ears 68project outward from the barrel member 56 on opposite sides of the slot66. Each ear includes a linear slot or track 70 (only one of which canbe seen in the figures) which extends at an acute angle, e.g., 15°, fromthe longitudinal axis of the barrel member, and oriented upward andoutward as shown in FIGS. 2 and 8-12. The bottom edge portion of thebarrel member includes a pair of pivot pins 72 projecting outwardtherefrom. The pins 72 are diametrically opposed and axially aligned,and each pin is configured to be disposed within a respective hole 54 inthe body member 44. When so located the barrel member is able to pivotwith respect to the body member about the axis of the aligned holes andpins to enable the barrel to assume any desired angular position withrespect to the body member from 0° (as shown in FIG. 8) to 40° (as shownin FIG. 9). The means for effecting the pivoting of the barrel memberwith respect to the base member is the heretofore identified slidemember 48.

Before describing the slide member, a description of the member forholding the needle 12 in the needle guide device 20 is in order. Thatmember is best seen in FIGS. 10 and 11. It is in the form of anelongated cylindrical needle holder or insert 74. The insert is moldedof any suitable plastic material and is configured to be disposed withinthe barrel member 46 to directly hold the needle 12 therein. Moreover,as will be seen and described later, the insert 74 is configured to berotated about the central axis 78 of the barrel member between an openposition, such as shown in FIG. 12, and a closed position, such as shownin FIG. 2, and vice versa. The insert 74 has a slot 76 extendingparallel to the central longitudinal axis 78 of the insert from one endof the insert to the other. The width of the slot 76 is just slightlylarger than the diameter of the particular diameter needle 12 to be usedwith the needle guide device. The inner end 80 of the slot 76 extendsparallel to the central longitudinal axis 78 and is circular in shape toaccommodate the needle 12 therein. The depth of the slot, i.e., thedistance from the outer surface of the insert (and the inner surface ofthe barrel member) to the inner end of the slot is just slightly largerthan the diameter of the needle. Thus, when the needle is inserted inthe slot 76 a portion of the periphery of the slot at the inner end 80engages the needle, while a portion of the inner surface of the barrelmember contiguous with the slot engages another portion of the peripheryof the needle, thereby holding the needle in place along a path that isparallel to the longitudinal central axis 78 of the needle holder. Thatpath establishes the trajectory for the needle.

It should be pointed out at this juncture that different inserts withdifferent size slots 76 can be provided in lieu of the insert 76 shownherein to accommodate different diameter needles.

As best seen in FIG. 11 the upper or entrance end of the slot 76 ischamfered or tapered to facilitate the axial introduction of the needletherein, i.e., the tapered or chamfered surface directs the distal endof the needle towards the slot when the needle is introduced axially.

A tab 82 projects radially outward from the top end of the insert toenable the user to rotate the insert 76 about central longitudinal axis78 within the barrel member between the open and closed positions. Inorder to accommodate the tab 82 the upper end of the barrel member has apair of notches 84 immediately adjacent each side of the slot 66. Theends of the notches establish a pair of stops enabling the insert to berotated through an angle of 180 degrees and no more.

When the needle holder or insert 74 is in the open position, like thatshown in FIG. 12, the needle 12 can be inserted laterally therein,instead of axially through the chamfered upper end of the insert asdiscussed above. To that end, the tab 82 is grasped by the user torotate the insert 74 180° about central longitudinal axis 78 (which isalso the longitudinal central axis of the barrel member) from theposition shown in FIGS. 1 and 2 to the position like shown in FIG. 12.At that time the slot 76 of the insert will be aligned with the slot 66of the barrel member, whereupon the needle can be inserted laterallythrough the aligned slots. Once the needle is in the slot 76 andparallel to the longitudinal central axis 78, the tab 82 can be rotated180° back to the closed position shown in FIGS. 1 and 2, thereby holdingthe needle in place.

As will be appreciated by one skilled in the art, after the needle hasbeen deployed, i.e., inserted into the patient's body along the desiredtrajectory, the imaging transducer 10 and needle guide device 20 can befreed (removed) from the needle leaving the needle 12 in place by merelyrotating the insert 74 to its open position, like shown in FIG. 12,whereupon the imaging transducer 10 and needle guide device 20 mountedthereon can be moved as a unit laterally with respect to the needle 12so that the needle passes through the aligned slots 66 and 77.

Turning now to FIGS. 10 and 11 the details of the construction andoperation of the slide member 48 will be described. The slide memberbasically comprises a generally planar body section 86 having athickened pair of side flanges 88, each of which includes alongitudinally extending slot or channel for receipt of a respectiveside edge 50A or 50B of the base member 44 to slidably mount the slidemember thereon. The central portion of the body section includes arecess or cavity 90 to accommodate the barrel member 46 when it is inits 0° orientation, i.e., when the slot 76 of the needle holder mountedwithin the barrel member extends parallel to the plane of the slot 62 ofthe base member. That orientation is shown in FIGS. 1 and 8. A pair ofears 92 project outward perpendicularly from the bottom of the bodysection 86 on each side of the slot 90. Each ear terminates in a freeend from which a pivot pin 94 projects. The pivot pins 94 are axiallyaligned and each is configured to be disposed within a respective one ofthe angularly extending tracks 70 of the barrel member.

When the slide member 48 is its upper-most position with respect to thebase member 46, the pivot pins 94 of the slide member will be at theupper ends of the tracks 70 of the barrel member, whereupon the barrelmember will be pivoted about its pivot pins 70 to the 0° angularorientation shown in FIG. 8. Conversely, when the slide member 48 is itslower-most position with respect to the base member 46, the pivot pins94 of the slide member will be at the lower ends of the tracks 70 of thebarrel member, whereupon the barrel member will be pivoted about itspivot pins 70 to the 40° angular orientation shown in FIG. 9.

The exemplary embodiment of the variable angle needle guide device 20shown herein includes a detent mechanism to hold the barrel member inany one of a number, e.g., seven, discrete distinct predeterminedangular orientations with respect to the base member, so that the slidemember can be readily and repeatedly slid to any one of those positionsand to be held therein against accidental displacement therefrom. Thedetent mechanism basically comprises a plurality of pairs of notches 96(FIGS. 10 and 11) extending along the sides 50A and 50B of the basemember at various predetermined spaced locations therealong and whichare configured to be engaged by pair of fingers on the slide member toreleasably hold the slide member at the position established by the pairof notches into which the fingers have been disposed. Thus, as can beseen, the slide member 48 includes a pair of pivotable arms 98 mountedon the side flanges 88. The upper end of each arm 98 is in the form of ahandle and a lower portion in the form of an inwardly directed free endfinger 100. Each arm is mounted on a respective one of the side flangesby a flexible bridge section 102, whereupon when the handles 98 aresqueezed together the flexible bridge sections 102 flex to cause the twoopposed fingers 100 to move apart from each other. That action frees thepair of fingers 100 from whatever pair of notches 96 they had beenlocated in so that the slide member 48 can then be slid to any otherposition with respect to the base member 44, whereupon the pair offingers are aligned with the pair of notches at that new position. Thehandles 98 can then be released, causing them to snap back to bring thefingers into those notches to releasably secure the slide in thatposition.

In order to facilitate usage of the needle guide device 20 to establisha desired angular trajectory for the needle, the device 20 includesindicia to provide an indication of the angle to which the needle guidehas been set. In particular, the needle guide includes a plurality ofletters, in this exemplary case the letters A through G, located on thefront surface of the base member 44. The notches associated with theletters A-G, establish the angles of 45°, 35°, 25°, 20°, 15°, 10°, and5°, respectively.

It should be pointed out at this juncture that the use of letters toindicate a desired angular orientation for the needle is merelyexemplary. Thus, the indicia may be in the form of numerical indiciadirectly identifying the angle, e.g., indicia stating “40°”, ornumerical indicia representing a particular angle. Alternatively, theindicia may be in the form of different colors representing differentangles or some other indicia representing different angles.

In any case, the top edge portion of the body section 86 includes a pairof windows 104 (FIG. 10) which are configured to expose the particularindicia, e.g., in this example the letters A-G, associated with the pairof notches 96 in which the pair of fingers 100 are located. Thus, theuser of the device can press on the handles 98 of the slide member tofree its fingers from the base member so that the slide member can beslid with respect to the base member until one of windows 104 exposesthe letter (or other indicia) associated with the desired angle for theneedle. The handles can then be released to enable the arms to springback, whereupon the fingers enter the associated notches, therebyreleasably locking the slide in that desired position.

It should be noted that while the needle guide device 20 as describedabove is configured so that the slide can be moved to any of the sevendiscrete positions established by the pairs of notches 96 to establishthe angled needle trajectory associated with that pair of notches, thespring bias provided by the flexible bridge sections 102 will hold thefree end of the fingers in sufficient frictional engagement with theside edges 50A and 5B of the base member between the notches 96. Thus,the slide member can be slid and held at a “free hand” position inbetween any of the notches. This feature is important to enable the userto establish a precise desired needle trajectory angle even if it isn'tone of the pre-established angles defined by the pairs of notches.

As discussed above, the needle guide 20 is configured to be directlymounted on an imaging transducer 10 which has been specially constructedor modified to include the heretofore described locating feature (e.g.,coupling member 16). The needle guide devices of this invention are alsosuitable for use on conventional imaging transducers, i.e., imagingtransducers without the locating feature or coupling member. To thatend, the heretofore mentioned adaptor bracket, constituting anotheraspect of this invention, is provided. The adaptor bracket 200 is bestseen in FIGS. 13-17 and enables a needle guide of this invention to beindirectly mounted on the prior art imaging transducer 10. The adaptorbracket 200 basically comprises a hollow housing 202 made of anysuitable material, e.g., a plastic. The housing is hollow and shaped toaccommodate the lower portion of whatever prior art imaging transducerit is to be used on. The housing 202 includes a front portion 204 and arear portion 206 disposed opposite to the front portion. The bottom ofthe housing is open to expose the working end of the imaging transducer10. In order to facilitate the disposition of the adaptor bracket 200 onthe bottom portion of the conventional imaging transducer, the housingis split to enable the housing to be opened like a clamshell. Inparticular the housing 202 includes a vertically oriented channel 208extending from the top edge of the housing at the back portion toapproximately the mid-height of the housing. The portion 210 of thehousing 202 between the bottom of the channel 208 and the bottom edge ofthe housing (i.e., the open bottom of the housing) forms the “hinge” ofthe clamshell arrangement. The front portion 204 of the housing is splitin half from its top edge to its bottom edge by means of a top channel212 and a bottom channel 214. The top channel merges with the bottomchannel and is slightly wider than the top channel.

In order to enable a needle guide device constructed in accordance withthis invention on the adaptor bracket 200, the front portion of thehousing 202 includes a coupling member 216. The coupling member 216 isconstructed like the coupling member 16 described heretofore, exceptthat it is split by the channel 214 into two halves. In particular, thecoupling member 216 includes one half on one side of the channel 214 andthe other half on the other side of that channel. Taken together the twohalf sections of the coupling member form of a projection of somewhatrectangular profile and having an enlarged top portion 116A and a pairof undercut recesses 116B on the opposed long sides of the projection,i.e., on one side of one half section and on the corresponding side ofthe other half section.

The mounting of the adaptor bracket 200 can be readily accomplished bygrasping portions of the front portion of the housing on opposite sidesof the channel 212 to open that channel, whereupon the two portions ofthe housing on opposite sides of the channel can pivot open about hinge210 so that the bottom portion of the conventional imaging transducer 10can be placed between the two open halves of the housing, with theworking end of the imaging transducer within the open bottom of thehousing. The housing can then be released so that it snaps back into itsnormally closed state on the imaging transducer like shown in FIG. 14. Acover 14 can then be placed over the adaptor bracket and the transducer.A needle guide device constructed in accordance with this invention canthen be releasably mounted on the coupling member as described abovewith reference to the needle guide 20.

Thus, any existing prior art imaging transducer can be readily retrofitby means of the adaptor 200 to accommodate the needle guide device 20(or any other needle guide device making use of the lockable mountingmember).

Turning now to FIGS. 18-20 and 22-24 the details of the fixed angleneedle guide device 20′ will now be described. That device makes use ofthe same lockable mounting member 24 for releasable mounting on the samecoupling member 16 or 216 as described heretofore. Thus, in the interestof brevity the common features of those components will be given thesame reference numbers and the details of their construction andoperation will not be reiterated.

As best seen in FIGS. 12-14 and 16-18, the needle guide device 20′basically comprises a needle guide assembly 122 and the lockablemounting member 24. Those components are each preferably molded of anysuitable plastic material. The needle guide assembly 122 basicallycomprises a base member 126 having a slot or channel 128 extendingthrough it from one side of the base member to the other side. Thechannel 128 is configured to slidably receive the lockable mountingmember 24 in a manner similar to the slot or channel 62 in theadjustable needle guide device 20. The back surface of the base member126 includes a recess 130.

With the lockable mounting member 24 in place within the slot or channel128 in its open position, the coupling member 16 of the transducer, witha portion of the cover 14 overlying the top 16A of the coupling 16, canbe extended through the recess 130 and through the window 38 in thelockable mounting member. Then the handle 26 of the lockable mountingmember can be pushed inward to move the lockable mounting member to thelocked position, whereupon the flanged projection 36 is located withinthe undercut recess 12B of the coupling member 16 or 216 to therebyreleasably mounting the needle guide device 20′ onto the imagingtransducer or on the adaptor bracket with the cover 14 interposedtherebetween.

The needle guide assembly also includes a barrel member 132 and a needleholder 134. The barrel member 132 is an elongated generally tubularmember having a slot 136 extending parallel to the central longitudinalaxis 138 of the barrel member from the top of the barrel member to thebottom thereof. The barrel member is fixedly mounted on the base member126 so that the longitudinal central axis 138 of the barrel member,which defines the needle trajectory, extends at a predetermined angle tothe base member 126. In the exemplary embodiment 20′ shown in FIGS.18-20, 22 and 24 the predetermined angle is 5° in relation to itsmounting member 126. In the exemplary embodiment 20″ shown in FIGS. 21and 25 the predetermined angle is 45° in relation to its mounting member126. The means for mounting the barrel member 132 in its particularangular orientation comprises a pair of arcuate struts 140 projectingoutward from the base member 126.

The needle holder 134 is in the form of an elongated cylindrical insertthat is configured to be disposed within the barrel member 132 todirectly hold the needle 12 therein. Moreover, the insert is configuredto be rotated about the longitudinal central axis 138 of the barrelmember between an open position, such as shown in FIG. 24, and a closedposition, such as shown in FIGS. 18 and 20, and vice versa. Theelongated cylindrical insert has a slot 142 extending parallel to thecentral longitudinal axis of the insert from one end of the insert tothe other. The width of the slot 142 is just slightly larger than thediameter of the particular diameter needle 12 to be used with the needleguide device 20′. The inner end of the slot 142 is circular in shape toaccommodate the needle 12 therein. The depth of the slot, i.e., thedistance from the outer surface of the insert 134 (and the inner surfaceof the barrel member 132) to the inner end of the slot is just slightlygreater than the diameter of the needle. Thus, when the needle isinserted in the slot 142 and the insert is in the closed position aportion of the periphery of the slot 142 engages a portion of theperiphery of the needle 12, while a portion of the inner surface of thebarrel member contiguous with the slot engages another portion of theperiphery of the needle, thereby holding the needle in place along apath that is parallel to the longitudinal central axis 138 of the needleholder. That path establishes the trajectory for the needle.

As is the case of the adjustable needle guide device 20, differentinserts or needle holders can be provided with different size slots 142to accommodate different diameter needles for use with a fixed angleneedle guide device, like device 20′. Moreover, like the needle holder74 of device 20, the needle holder of device 20′ makes use of a slot 142whose upper end is chamfered to facilitate the axial introduction of theneedle therein.

A tab 144 projects radially outward from the top end of the insert 132to enable the user to rotate the insert about central longitudinal axis138 within the barrel member 134 between the open and closed positions,and vice versa. In order to accommodate the tab 144 the upper end of thebarrel member has an internal T-shaped slot having an elongated portion146 extending about a portion of the periphery of the barrel member justbelow the top edge thereof and an entry portion 148 extending from thetop edge to the elongated portion 146. The tab 144 includes a narrowsection where the tab merges with the tubular insert and which isconfigured to be introduced through the entry portion 148 of theT-shaped slot and then into the elongated portion of that slot. Theelongated portion of the T-shaped slot is of a sufficient length toenable the insert 132 to be rotated about an angle of approximately 180°between the closed position and the open position, and vice versa, whenthe tab 144 is within the elongated portion 146 of the slot.

It should be pointed out at this juncture that when the needle holder orinsert 132 is in the open position, like that shown in FIG. 24, theneedle 12 can be inserted therein laterally instead of axially throughthe chamfered upper end of the insert as discussed above. In particular,the tab is grasped by the user to rotate the insert 180° about centrallongitudinal axis 138 (which is also the longitudinal central axis ofthe barrel member) from the position like shown in FIGS. 18 and 19 tothe position like shown in FIG. 24. At that time the slot 142 of theinsert will be aligned with the slot 136 of the barrel member, whereuponthe needle 12 can be inserted laterally through the aligned slots. Oncethe needle is in the slot 142 the tab 144 can be rotated 180 degreesback to the closed position shown in FIGS. 18 and 19, thereby holdingthe needle in place.

After the needle has been deployed, i.e., inserted into the patient'sbody along the desired trajectory, the imaging transducer 10 and needleguide device 20′ that is mounted thereon can be freed (removed) from theneedle leaving the needle in place by merely rotating the insert 74 toits open position, like shown in FIG. 18, whereupon the transducer andneedle guide device can be moved as unit laterally with respect to theneedle so that the needle passes through the aligned slots 136 and 142.

In FIG. 21 there is shown an alternative embodiment of a fixed angleneedle guide device 20″ constructed in accordance with this invention.The needle guide device 20″ is virtually identical in construction tothe needle guide device 20′, except that it establishes a greater angledtrajectory for the needle, i.e., a 40° angle with respect to the bodymember 126. To that end, the struts 140 are of a longer length, e.g.,establish an angle of 40°. In the interest of brevity the commonfeatures of the embodiments of the devices 20′ and 20″ will be given thesame reference numbers and the details of their construction andoperation will not be reiterated.

As mentioned above the subject invention contemplates providing a kit ofplural fixed angle needle guide devices, like device 20′ and 20″ as wellas others establishing other fixed angles desired for use.

Like the adjustable needle guide device 20, the fixed angle devices 20′,20′ and any other fixed angle device, are configured to be directlymounted on an imaging transducer which has been specially constructed ormodified to include the heretofore described locating feature, e.g., thecoupling member 16, and with a cover interposed therebetween. Forapplications making use of a conventional imaging transducer, thebracket or adaptor 200, like shown in FIG. 14, can be used with thefixed angle needle guide device. For example, FIG. 25 shows aconventional imaging transducer 10 on which an adaptor 200, like thatdescribed above, has been mounted and over which a conventional cover 14has been disposed. In that embodiment the fixed needle guide device 20″is releasably mounted to the coupling member 16 of the adaptor, with thecover interposed therebetween.

It should be pointed out at this juncture that various modifications canbe made to the structure of the needle guide devices, the couplingmembers and the adaptor brackets within the scope of this invention. Byway of example, and not limitation, the slidable connection between thecoupling member of the imaging transducer or the adaptor bracket and thelockable mounting member can be reversed from the exemplary embodimentdescribed above. Thus, instead of the lockable mounting member of theneedle guide device having a projection which is configured to bereceived within a recess in the coupling member of the imagingtransducer or the adaptor bracket, the lockable mounting member can makeuse of a recess, e.g., an undercut recess, while the coupling member canmake use of a projection for slidable receipt in the recess of thelockable mounting member. Moreover, the recess on the coupling member orthe recess on the lockable mounting member (if the components arereversed) need not be located as shown in the exemplary embodiment,e.g., on the sides of the coupling member, but can be in any suitablelocation to effect the slidable, releasably locking engagement betweenthe coupling member and the lockable mounting member. Furthermore, thepivotable connection between the slide member and the barrel member canbe reversed from the exemplary embodiment described above, i.e., theadjustable angle needle guide can make use of a barrel having at leastone projecting fingers and a slide member having an ear with at leastone angularly extending track or slot for receipt of the at least onefinger. Similarly, the pivotable connection between the slide member andthe body member can be reversed from the exemplary embodiment describedabove, i.e., the barrel member can include a pair of aligned holes andthe body member can include a pair of pins for receipt in the alignedholes to enable the barrel member to pivot thereabout.

In view of the foregoing it should be appreciated by those skilled inthe art that the common locating feature, e.g., the coupling member, ofthis invention can be applied to most general purpose ultrasoundtransducers. That common locating feature can be easily cleaned.Moreover, it is shaped similar to a #1 array indicator, so users of theinvention should feel familiar with it. Moreover, the structure andarrangement of the common locating feature causes minimal interferenceor discomfort during scanning, yet provides stable support of for theneedle guide device. Further still, the locating feature allowsattachment without damaging an ultrasound cover. Insofar as the needleguide device is concerned, it enables one to fix the trajectory angle ofthe device and also allows for user selection of multiple trajectories.The device incorporates functionality where the user can change theneedle trajectory angle before or after assembly to a transducer,bracket and/or insertion of the needle therein. Further yet, the needleguide device provides visible indicia in the form of acharacter/number/identification element for each needle path trajectory,allowing the user to identify the trajectory and manually select thecorresponding guidelines overlay on the ultrasound system. In accordancewith one preferred aspect of the invention the needle guide devicesenable the establishment of an angular range of at least 40° and canmaintain a close proximity to the transducer to achieve a minimal “blindzone”. The needle guide devices of this invention accept multipleversions of inserts sized for differing needle diameters. Whether afixed angle needle guide device or a variable need guide device, aneedle guide device constructed in accordance with this inventionexhibits a form factor that is minimal near the transducer lens so asnot to interfere with scanning and has a sufficiently low profilewithout any fixed features that extend past the needle path.

Referring now to FIG. 26 another, and more preferred, exemplaryembodiment of a reusable needle guide device 320 constructed inaccordance with this invention is shown. The needle guide device 320 isconfigured to be releasably mounted directly on an imaging instrument,e.g., an ultrasound transducer or probe 10 like shown in FIGS. 26 and27, or mounted on an adapter bracket 400 constructed in accordance withthis invention and shown in FIGS. 43 and 44. In any case the device 320when mounted on a transducer 10 or on an adaptor 400 which in turn ismounted on a transducer serves to mount and guide a needle 12 or anyother elongated instrument through a desired path or trajectory into thebody of a patient (human or animal) for a tissue biopsy procedure or anynumber of other medical procedures.

As will be seen and described in detail later the needle guide device320 is adjustable, so that it can establish a trajectory path enablingthe needle or instrument to reach an internal site in the patient's bodythat is close to or far away from the distal or working end of thetransducer. In particular, the needle guide device 320 is configured toenable the user to adjust the needle angle trajectory through a widerange.

The exemplary needle guide device 320 (and any other needle guide deviceconstructed in accordance with this invention) makes use of a mountingfeature to enable it to be readily and quickly mounted on an imagingtransducer 10 either with or without a conventional cover 14 interposedtherebetween. If a cover is used it will typically be formed of a thin,flexible sheath of any suitable material, e.g., latex, into a suitableshape, e.g., a condom-shaped sheath, to be placed over the imagingtransducer before the needle guide device is mounted thereon to keep thetransducer sanitary. In the interest of drawing simplicity the cover hasbeen omitted from figures of the drawing of the embodiment 320, it beingunderstood that the cover can be interposed between the needle guidedevice and the imaging transducer on which the needle guide device ismounted. Alternatively the cover can be interposed between the needleguide device and the adapter bracket on. In either such case the needledevice can be releasably mounted without breaching the cover.

The releasably mounting feature of this invention will be described indetail later. Suffice it for now to state that the exemplary needleguide device 320 includes a lockable mounting assembly arranged to bereleasably secured to a universal or common locating feature or couplingmember that is provided on the housing of a specially constructedimaging transducer or on an adapter bracket for use on a conventionalimaging transducer. The lockable mounting assembly includes a slidablemember (e.g., a lock slide to be described later) that is configured tobe slid from an unlocked position to enable the needle guide device tobe mounted on the coupling member, to a locked position wherein theneedle guide is releasably locked or secured to the coupling member andhence to the transducer.

As will also be described later the needle guide device 320 (and allother needle guides constructed in accordance with subject invention) isconfigured to enable the user to adjust the angle of penetration for theneedle between a minimum angle and a maximum angle. When adjusted to themaximum angle the needle guide device enables a very shallow depth ofpenetration for the needle, with a minimal blind spot, without anyportion of the needle guide device projecting far out from thetransducer to block the view of the user. Thus, the needle guide device320, like other needle guide devices of this invention, has a compactform factor.

Turning now to FIGS. 26, 27 and 31 it can be seen that the exemplaryneedle guide device 320 basically comprises a needle guide assembly 322and a lockable mounting assembly 324. The lockable mounting assembly 324is configured to be releasably secured to a universal or common locatingcoupling member 316 that is located on the housing of the transduceradjacent the distal or working end of the transducer. The couplingmember 316 is preferably mounted at the location of the typical “#1array indicator” of a conventional ultrasonic transducer. In the casewhere the common locating coupling member 316 is used on an adapterbracket 400, it will be located on that bracket at a positioncorresponding to the position that the coupling member is mounted on thetransducer itself.

As best seen in FIGS. 28-31 the coupling member 16 is in the form of aprojection of somewhat regular profile and having an enlarged generallyplanar front surface portion 316A, an undercut recesses 316B on the leftside of the projection, an undercut recess 316C on the right side of theprojection, and an undercut recess 316D on the top side of theprojection. As best seen in FIG. 30, the undercut recess 316D slantsdownward symmetrically from the center of the top side towards the leftside of the projection and also toward the right side of the projection.

The lockable mounting assembly 324 is best seen in FIGS. 32-36B andbasically comprises a slidable member or lock slide 310 and a lock lever312. Each is molded of a suitable plastic material. The lock slide 310is a generally planar frame-like member having a generally linear sidesurface 310A and a pair of projecting ears 310B and 310C (FIG. 34)located on opposite sides of the surface 310A. The surface 310Aconstitutes an engagement surface configured to mate with (be receivedwithin) the left side undercut recess 316C of the projection 316 whenthe lockable mounting assembly is in the locked position. The lock slideincludes an opening 310D for receipt of portions of the lock lever 312(to be described later). The lock slide is arranged for slidable receiptwithin an undercut slot 302 in a body or base member 304 of the needleguide device to enable the lock slide to be slid between the unlockedposition (not shown) and the locked position (FIG. 33), and vice versa.The body or base member 304 of the needle guide device forms a portionof the needle guide assembly 322. As best seen in FIG. 34 the undercutslot 302 includes short front edge surface 302A and an opposed pair oflinear surfaces 302B and 302C which between them define the entryway tothe undercut slot. The end of the slot opposite the slot's entryway isin the form of a generally planar, linear projection 306 overlying theslot. The ears 310B and 310C of the lock slide are configured to beintroduced into the undercut slot by locating them within the portionsof the slot contiguous with the surfaces 302B and 303C, respectively,and then sliding the lock slide towards projection 306. The projection306 forms a stop surface which is configured to mate with (be receivedwithin) the right side undercut recess 316C of the coupling member(projection) 316 when the lockable mounting assembly is in the lockedposition, whereupon the projection 316 is tightly sandwiched between theengagement surface 310A and the stop surface 306.

The means for sliding the lock slide 310 between the unlocked positionand the locked position, and vice versa, is the heretofore identifiedlock lever 312. As can be seen in FIGS. 35, 36A and 36B the lock lever312 basically comprises a finger grip portion 312A, a pivot pin portion312B (FIG. 36B), and a cam portion 312C. The pivot pin 312B is a splitmember of circular profile having an enlarged head 312D at the free endthereof. A small tab 312E projects outward from the head 312D. As bestseen in FIG. 36A the cam 312C is laterally offset from the central axisof the pivot pin 312B. The cam 312C is configured to be located withinthe opening 310D of the lock slide 310, with the pivot pin 312B beinglocated within a hole 304A in a projecting portion 304B of the bodymember 304 adjacent the slot 302 and with the head 312D of the pivot pinlocated on the opposite side of the projection 304B as the slot 302. Thehole includes a recess 304C (FIGS. 32 and 34) which is provided for thepurpose of providing an opening to allow tab 312E to fit through. Thetab 312E is configured to fit through the recess 304C.

The pivot pin 312B is arranged to be pivoted within the hole 304A aboutits central axis by the finger grip 312A to cause the cam 31C to engageportions of the lock slide to move it to either the locked or unlockedpositions, depending upon the direction of notation of the pivot pin312B. In particular, since the cam 312C is laterally offset from thecentral axis of the pivot pin 312B, and since the cam is located withinthe opening 310D of the lock slide 310, the pressing downward on thefinger grip 312A effects the clockwise rotation of the pivot pin,whereupon a portion of the surface of the cam pushes on a portion of theslide lock contiguous with the opening 310D towards the stop surface 306to the locked position. Conversely, pressing upward on the finger gripeffects the counter-clockwise rotation of the pivot pin, whereupon aportion of the surface of the cam pushes on a diametrically opposedportion of the slide lock contiguous with the opening 310D away from thestop surface 306 to move the slide lock to the unlocked position.

The releasable mounting of the needle guide device 320 onto a transducerhaving a coupling member 316 or onto an adapter bracket 400 including asimilarly constructed coupling member is achieved as follows. The fingergrip 312A of the lock lever 312 is pressed upward to move the slide lockto the unlocked or open position (if the slide lock is not already inthat position). The needle guide device 320 and the transducer oradapter bracket 400 are then moved relative to each other so that thecoupling member or projection 316 is located within the undercut slot302 between the engagement surface 310A and the stop surface 306. Oncethat has been accomplished the finger grip 312A of the lock lever ispressed downward, to cause the cam 312C to engage a portion of the slidelock 310 contiguous with the opening 310D to slide the slide locktowards the stop surface 306, whereupon the stop surface is locatedwithin the right side recess 316C of the projection and the engagementsurface 310 of the slide lock is located in the left side recess 316B ofthe projection whereupon the coupling member 316 is tightly sandwichedbetween the engagement surface 310A and the stop surface 306. Thisaction effectively releasably secures the needle guide device onto thetransducer or adapter bracket so that it is ready for use. To remove theneedle guide device from the transducer or adapter bracket, when such isdesired, all that is required is to press upward on the finger grip 312Aof the lock lever to cause the cam 312B to engage a diametricallyopposed portion of the slide lock contiguous with the opening 310D toslide the slide lock away from the stop surface 306, thereby freeing thecoupling member 316 so that it can be removed from the undercut slot302.

Referring now to FIGS. 31, 37-42 the details of the needle guideassembly 322 will now be described. To that end, it basically comprisesthe heretofore identified body or base member 304, a needle holdersubassembly 346 and a slide member 348. Each is molded of a suitableplastic material. The body member 304 comprises a generally flat panelhaving a pair of long sides 350A and 350B. A pair of triangularly shapedflanges 352A and 52B project rearwardly from the bottom portions of thesides 350A and 350B, respectively. The inner surface of each flangeincludes a short slot terminating in a circular hole 354 foraccommodating a respective pivot pin of a cylindrically shaped barrelmember 356 (to be described shortly) forming a portion of the needleholder subassembly 346. The holes 354 are axially aligned. The frontportion of the body member 304 includes an arcuate recess or cavity 360,as best seen in FIGS. 32 and 40, which is configured to accommodate thebarrel member 356.

The barrel member 356 forms a portion of the needle holder subassembly346 and is an elongated generally tubular member having a centrallylocated linear front slot 366 (FIG. 41) extending parallel to thecentral longitudinal axis of the barrel member. A pair of triangularears 368 project outward from the barrel member 356 on opposite sides ofthe slot 366. Each ear 368 includes a linear slot or track 370 whichextends at an acute angle, e.g., 15°, from the longitudinal axis of thebarrel member, and oriented upward and outward as shown in FIGS. 31, 39and 141. As best seen in FIG. 41, the bottom edge portion of the barrelmember includes a pair of axially aligned pivot pins 372 projectingoutward therefrom (although only one the pins can be seen). The pins 372are configured to be disposed within respective holes 354 in the bodymember 304. When so located the barrel member is able to pivot withrespect to the body member about the axis of the aligned holes to enablethe barrel to assume any desired angular position with respect to thebody member from 0° (as shown in FIGS. 26 and 27) to 40° (as shown inFIGS. 27 and 38). The means for effecting the pivoting of the barrelmember with respect to the base member is the heretofore identifiedslide member 248.

Before describing the slide member 248, a description of the member forholding the needle 12 in the needle guide device 320 is in order. Thatmember forms a portion of the needle holder subassembly 346 and is bestseen in FIG. 41. It is in the form of an elongated cylindrical needleholder or insert 374. The insert is molded of any suitable plasticmaterial and is configured to be disposed within the barrel member 346to directly hold the needle 12 therein. Moreover, as will be seen anddescribed later, the insert 374 is configured to be rotated about thecentral longitudinal axis 378 of the barrel member between an openposition, such as shown in FIG. 41, and a closed position, such as shownin FIGS. 33 and 39, and vice versa. The insert 374 has a slot 376extending parallel to the central longitudinal axis of the insert fromone end of the insert to the other. The width of the slot 376 is justslightly larger than the diameter of the particular diameter needle 12to be used with the needle guide device. The inner end of the slot 376extends parallel to the central longitudinal axis of the insert and iscircular in shape to accommodate the needle 12 therein. The depth of theslot, i.e., the distance from the outer surface of the insert (and theinner surface of the barrel member) to the inner end of the slot is justslightly larger than the diameter of the needle. Thus, when the needleis inserted in the slot 376 a portion of the periphery of the slot atthe inner end engages the needle, while a portion of the inner surfaceof the barrel member contiguous with the slot engages another portion ofthe periphery of the needle, thereby holding the needle in place along apath whose longitudinal axis 378 is parallel to but slightly laterallyoffset from the central longitudinal axis of the needle holder. Thatpath establishes the trajectory for the needle. The upper or entranceend of the slot 376 is chamfered or tapered to facilitate the axialintroduction of the needle therein, i.e., the tapered or chamferedsurface directs the distal end of the needle towards the slot when theneedle is introduced axially.

It should be pointed out at this juncture that different inserts withdifferent size slots 376 can be provided in lieu of the insert shownherein to accommodate different diameter needles.

A tab 82 projects radially outward from the top end of the insert toenable the user to rotate the insert 376 about central longitudinal axisof the barrel member within the barrel member between the open andclosed positions. In order to accommodate the tab 382 the upper end ofthe barrel member has a pair of notches 384 immediately adjacent eachside of the slot 366. The ends of the notches establish a pair of stopsenabling the insert to be rotated through an angle of 180 degrees and nomore.

When the needle holder or insert 374 is in the open position the slot376 of the needle holder is aligned with the slot 266 of the barrelmember the needle 12 can be inserted laterally through the alignedslots, instead of axially through the chamfered upper end of the needleholder as discussed above. To that end, the tab 382 is grasped by theuser to rotate the needle holder 180° about central longitudinal axis378 (which is also the longitudinal central axis of the barrel member)from the closed position shown in FIGS. 31 and 39 to a position likeshown in FIG. 41 where the slots 376 and 366 are aligned, whereupon theneedle can be inserted laterally through the aligned slots. Once theneedle is in the slot 376 along axis 378, the tab 382 can be rotated180° back to the closed position shown in FIGS. 6 and 14, therebyholding the needle in place.

As will be appreciated by one skilled in the art, after the needle hasbeen deployed, i.e., inserted into the patient's body along the desiredpath or trajectory, the imaging transducer 10 and needle guide device 20can be freed (removed) from the needle leaving the needle 12 in place bymerely rotating the insert 374 to its open position, whereupon theimaging transducer 10 and needle guide device 320 mounted thereon can bemoved as a unit laterally with respect to the needle 12 so that theneedle passes through the aligned slots 376 and 366.

Turning now to FIGS. 6, 15 and 16 the details of the construction andoperation of the slide member 348 to pivot the needle holder assembly tothe desired angle will be described. The slide member basicallycomprises a generally planar body section 386 having a pair of sideflanges 388 projecting backward from respective side edges of the bodysection 386. Each flange 388 includes a longitudinally extending slot orchannel 388A (FIG. 31) for receipt of a respective side edge 350A or350B of the base member 304 to slidably mount the slide member on thebase member. The central portion of the body section 386 includes arecess or cavity 390 to accommodate the barrel member 346 when it is inits 0° orientation, i.e., when the slot 376 of the needle holder mountedwithin the barrel member extends parallel to the plane of the undercutslot 302 of the base member 304. A pair of ears 392 project outwardperpendicularly from the lower portion of the body section 386 on eachside of the slot 390. Each ear terminates in a free end from which apivot pin 394 projects. The pivot pins 394 are axially aligned and eachis configured to be disposed within a respective one of the angularlyextending tracks 370 of the barrel member.

When the slide member 348 is its upper-most position with respect to thebase member 304, the pivot pins 394 of the slide member will be at theupper ends of the tracks 370 of the barrel member, whereupon the barrelmember will be pivoted about its pivot pins 372 to the 0° angularorientation shown in FIGS. 26 and 37. Conversely, when the slide member348 is its lower-most position with respect to the base member 304, thepivot pins 394 of the slide member will be at the lower ends of thetracks 370 of the barrel member, whereupon the barrel member will bepivoted about its pivot pins 372 to the 40° angular orientation shown inFIGS. 27 and 38.

The exemplary embodiment of the variable angle needle guide device 320shown herein includes a locking mechanism to hold the barrel member inany one of a number, e.g., five, discrete distinct predetermined angularorientations with respect to the base member, so that the slide membercan be readily and repeatedly slid to any one of those positions and tobe held against accidental displacement therefrom. The locking mechanismbasically comprises a plurality of notches 396 (FIGS. 39 and 40) and aslide lock 398. The notches 396 extend along the side 350B of the basemember 304 at various predetermined spaced locations therealong. Eachnotch is configured to be engaged by the slide lock 398 to hold theslide member at the position established by the selected notch. Theslide lock is slidably mounted on the slide member via a flanged rail330 (FIGS. 40 and 41) extending along the ear 392 adjacent the rightside of the slide member. The flanged rail is configured for slidablereceipt in the slide lock. The slide lock is best seen in FIGS. 41 and42 and basically comprises a member having a somewhat hollow bodyincluding a T-shaped slot 398A in the bottom portion thereof and aL-shaped flange 398B projecting outward from the inner end of the slidelock. The T-shaped slot is arranged to receive the flanged rail 330(FIG. 40) of the slide member to enable the slide lock to be slidtherealong from an unlocked or retracted position to a locked orextended position, and vice versa. A slot 386A is located adjacent theflanged rail 330 and extends through the channel 388A. When the slidelock is in the extended or locked position the upper section of theL-shaped flange 398B will extend through the slot 386A for dispositionin any one of the notches 396 to thereby hold the slide member 348 inplace with respect to the body member 304. When the slide member is inthe retracted or unlocked position, the upper section of the L-shapedflange 398B will be located outside all of the notches so that the slidemember can be slid up or down the body member to any desired positiontherealong. The slide lock includes a detent mechanism to ensure thatthe slide lock does not become disconnected from the flanged rail whenit is in the refracted position.

In order to facilitate usage of the needle guide device 320 to establisha desired angular trajectory for the needle, the device 320 includesindicia to provide an indication of the angle to which the needle guidehas been set. In particular, the needle guide includes a plurality ofletters, in this exemplary case the letters A through E, located on thefront surface of the base member 304. The notches associated with theletters A-E, establish the angles of 40°, 28°, 18°, 9°, and 3°,respectively.

It should be pointed out at this juncture that the use of letters toindicate a desired angular orientation for the needle is merelyexemplary. Thus, the indicia may be in the form of numerical indiciadirectly identifying the angle, e.g., indicia stating “28°”, ornumerical indicia representing a particular angle. Alternatively, theindicia may be in the form of different colors representing differentangles or some other indicia representing different angles.

In any case, the body section 386 includes a window 332 (FIGS. 39-41)which is configured to expose the particular indicia, e.g., in thisexample the letters A-E, associated with the notches 396 in which slidelock's L-shaped flange is located. Thus, the user of the device canpress on the top surface of the slide lock to slide it to the refractedor unlocked position to free it from the base member so that the slidemember can be slid with respect to the base member until the window 332exposes the letter (or other indicia) associated with the desired anglefor the needle. The slide lock can then be slid back to the extended orlocked position, whereupon the upper section of the L-shaped flange 398Benters the associated notch 396, thereby releasably locking the slidemember in that desired position.

It should be pointed out at this juncture that the needle guide device320 can be used to establish an angular orientation for the needle thatis different than the predetermined angles established by the notches396, since the construction of the slide member is such that it iscontinuously slidable with respect to the base member to any positionbetween discrete positions established by those notches. In such a case,all that the user has to do is slide the slide member to the desiredposition along the base member to establish a desired angle for theneedle while keeping the slide lock 398 in its retracted or unlockedposition. When the slide lock is in the unlocked position, the uppersection of the L-shaped flange 398B will be located outside all of thenotches so that the slide member will effectively be floating and can beslid up or down the body member to any desired position therealong toestablish any desired angle for the needle. Thus, the needle guidedevice 320, and other needle guide devices constructed in accordancewith this invention, can be used to guide needles or other elongatedinstruments within the center elevation plane of the transducer allowingfree angle movement in relation to the center azimuth plane of thetransducer by leaving the slide lock in the unlocked position.

As discussed above, the needle guide 320 is configured to be directlymounted on an imaging transducer 10 which has been specially constructedor modified to include the heretofore described locating feature (e.g.,the coupling member 316). The needle guide devices of this invention arealso suitable for use on conventional imaging transducers, i.e., imagingtransducers without the locating feature or coupling member. To thatend, the heretofore mentioned adaptor bracket 400, constituting anotheraspect of this invention, is provided. The adaptor bracket 400 is bestseen in FIGS. 43 and 44 and enables a needle guide device of thisinvention to be indirectly mounted on any prior art imaging transducer.To that end, the adaptor bracket 400 basically comprises a hollowhousing 402 made of any suitable material, e.g., a plastic. The housingis hollow shaped to accommodate the lower portion of whatever prior artimaging transducer it is to be used on. The housing 402 includes a frontportion 404 (FIG. 43) and a rear portion 406 (FIG. 44) disposed oppositeto the front portion. The bottom of the housing is open at 408 to exposethe working end of a conventional imaging transducer 10. In order tofacilitate the disposition of the adaptor bracket 400 on the bottomportion of the imaging transducer, the housing is split to enable it tobe opened like a clamshell. In particular, the housing 402 includes avertically oriented channel 410 extending from the top edge of thehousing at the back portion to approximately the mid-height of thehousing. The portion of the housing between the bottom of the channel410 and the bottom edge of the housing (i.e., the open bottom 408) formsthe “hinge” of the clamshell arrangement. The front portion 404 of thehousing is split in half from its top edge to its bottom edge by meansof a top channel 412A and a contiguous bottom channel 412B. The topchannel is aligned with and merges with the bottom channel and isslightly wider than the bottom channel.

In order to enable a needle guide device constructed in accordance withthis invention to be releasably mounted on the adaptor bracket 400, thefront portion 404 of the housing 402 includes a locating feature ofcoupling member like that described previously. In particular thecoupling member of the adaptor bracket 410 is constructed like thecoupling member 316 described heretofore, except that it is split by thelower channel 412B into two halves, i.e., a left half and a right half.In particular, the coupling member 316 includes one half on one side ofthe channel 412B and the other half on the other side of that channel.Taken together the two half sections of the coupling member 316 form ofa projection of the same shape as described earlier with respect to thecoupling member forming a part of the transducer housing.

The mounting of the adaptor bracket 400 on a conventional transducer 10can be readily accomplished by grasping portions of the front portion404 of the housing 402 on opposite sides of the channels 412A and 412Bto open those channels, whereupon the two portions of the housing 402 onopposite sides of the channel can pivot open like the opening of aclamshell so that the bottom portion of the conventional imagingtransducer 10 can be placed between the two open halves of the housing,with the working end of the imaging transducer within the open bottom ofthe housing. The housing can then be released so that it snaps back intoits normally closed state on the imaging transducer like shown in FIG.43. If desired a cover (not shown) can then be placed over the adaptorbracket and the transducer. A needle guide device constructed inaccordance with this invention can then be releasably mounted on thecoupling member as described above.

It should thus be apparent to those skilled in the art that any existingprior art imaging transducer can be readily retrofit by means of theadaptor 400 to accommodate the needle guide device 320 (or any otherneedle guide device in accordance with this invention).

Various modifications can be made to the structure of the needle guidedevices, the coupling members and the adaptor brackets within the scopeof this invention. By way of example, and not limitation, the slidableconnection between the coupling member of the imaging transducer or theadaptor bracket and the lockable mounting member can be reversed fromthe exemplary embodiment described above. Thus, instead of the slidelock member 310 of the needle guide device having a projection which isconfigured to be received within a recess in the left side of thecoupling member of the imaging transducer or the adaptor bracket, theslide lock can make use of a recess, e.g., an undercut recess, while theleft side of coupling member can make use of a projection for slidablereceipt in the recess of the slide lock. So too, the projection or stop306 can be in the form of a recess at its free end, while the right sideof coupling member includes a projection for receipt in the stop 306, solong as the coupling member is tightly sandwiched between opposingsurfaces to releasably secure the needle guide device onto the couplingmember. Furthermore, the pivotable connection between the slide memberand the barrel member can be reversed from the exemplary embodimentdescribed above, i.e., the adjustable angle needle guide can make use ofa barrel having at least one projecting fingers and a slide memberhaving an ear with at least one angularly extending track or slot forreceipt of the at least one finger. Similarly, the pivotable connectionbetween the slide member and the body member can be reversed from theexemplary embodiment described above, i.e., the barrel member caninclude a pair of aligned holes and the body member can include a pairof pins for receipt in the aligned holes to enable the barrel member topivot thereabout.

In view of the foregoing it should be appreciated by those skilled inthe art that the common locating feature, e.g., the coupling member, ofthis invention can be applied to most general purpose ultrasoundtransducers. That common locating feature can be easily cleaned.Moreover, it is shaped similar to a #1 array indicator, so users of theinvention should feel familiar with it. Moreover, the structure andarrangement of the common locating feature causes minimal interferenceor discomfort during scanning, yet provides stable support of for theneedle guide device. Further still, the locating feature allowsattachment without damaging an ultrasound cover, if such is used.

Insofar as the needle guide device is concerned, it enables one to fixthe trajectory angle of the device and also allows for user selection ofmultiple trajectories. The device incorporates functionality where theuser can change the needle trajectory angle before or after assembly toa transducer, bracket and/or insertion of the needle therein.

Further yet, the needle guide device provides visible indicia in theform of a character/number/identification element for each needle pathtrajectory, allowing the user to identify the trajectory and manuallyselect the corresponding guidelines overlay on the ultrasound system. Inaccordance with one preferred aspect of the invention the needle guidedevices enable the establishment of an angular range of at least 40° andcan maintain a close proximity to the transducer to achieve a minimal“blind zone”. The needle guide devices of this invention accept multipleversions of inserts sized for differing needle diameters. Further still,needle guide devices constructed in accordance with this inventionexhibit a form factor that is minimal near the transducer lens so as notto interfere with scanning and has a sufficiently low profile withoutany fixed features that extend past the needle path.

Without further elaboration the foregoing will so fully illustrate myinvention that others may, by applying current or future knowledge,adopt the same for use under various conditions of service.

What is claimed is:
 1. A needle guide device configured for releasablemounting on an imaging transducer or on an adaptor on an imagingtransducer, the imaging transducer or the adaptor including a couplingmember comprising a rectangular portion projecting outwardly from theimaging transducer or the adapter, wherein the rectangular portionincludes first and second undercut recesses on opposing sides of therectangular portion, said needle guide device comprising: a lockablemounting assembly; and a needle guide assembly coupled to the lockablemounting assembly to retain a needle at a desired trajectory withrespect to the imaging transducer, wherein said needle guide assemblycomprises: a body member, and a needle holder, said body membercomprising a recess for receiving the coupling member therein, whereinthe recess comprises a stop portion configured to engage the firstundercut recess in the coupling member when the needle guide device islocked to the imaging transducer or the adaptor, wherein said lockablemounting assembly comprises: a slidable member having an engagementportion configured to engage the second undercut recess when the needleguide device is locked to the imaging transducer or the adaptor, and acam portion coupled to the slidable member and the body member via apivot pin, wherein the cam portion is laterally offset from a centralaxis of the pivot pin, such that rotation of the cam portion about thepivot pin causes the slidable member to slide laterally relative to thestop portion in the body member between the locked and unlockedpositions, said lockable mounting assembly being configured to beslidably coupled to said body member and slidable from an unlockedposition to a locked position and vice versa, such that when moved fromthe unlocked position to the locked position, the stop portion of thebody member engages the first undercut recess and the engagement portionof the slidable member engages the second undercut portion to clampinglysecure the needle guide device to the coupling member.
 2. The needleguide device of claim 1, wherein said body member comprises a slotpositioned adjacent to said recess for receiving at least a portion ofsaid slidable member.
 3. The needle guide device of claim 1, whereinsaid needle holder is adjustably mounted on said body member to enablesaid needle holder to be oriented to various selected orientations withrespect to said body member to establish various angled trajectories forthe needle.
 4. The needle guide device of claim 3, wherein said needleguide assembly further comprises: a needle holder subassembly, and aslide member, wherein said needle holder subassembly comprises: a barrelmember, and said needle holder, said needle holder being located withinsaid barrel member, said barrel member being pivotably mounted on saidbody member, wherein said slide member is slidable with respect to saidbody member, in a plane parallel to a plane of a front surface of saidbody member, and is further coupled to said barrel member to pivot saidbarrel member with respect to said body member to a first angularorientation when said slide member is slid to a first position, and topivot said barrel portion with respect to said body member to a secondangular orientation when said slide member is slid to a second position,wherein said needle holder establishes a first angular trajectory forthe needle when said barrel member is in said first angular orientationand a second angular trajectory for the needle when said barrel memberis in said second angular orientation, wherein said second angulartrajectory is different than said first angular trajectory.
 5. Theneedle guide device of claim 4, wherein said barrel member is pivotablewith respect to said body member through an angle of approximately 40degrees to establish an angular range of trajectories for the needlefrom 0 degrees to approximately 40 degrees with respect to said bodymember.
 6. The needle guide device of claim 4, wherein said slide memberincludes at least one projecting ear having a free end, wherein saidbarrel member comprises a recessed track oriented angularly with respectto a longitudinal axis of the barrel member, wherein said free end ofsaid projecting ear is slidably coupled to said recessed track,whereupon sliding of said slide member with respect to said body membercauses said free end of said projecting ear to slide within saidangularly oriented recessed track to pivot said barrel member withrespect to said body member.
 7. The needle guide device of claim 4,wherein said slide member is slidable to more than two distinctpredetermined positions with respect to said body member to establishmultiple predetermined angular orientations for the needle.
 8. Theneedle guide device of claim 4, including indicia, one of said indiciabeing visible when said slide member is in said first position to enablethe user to confirm the location of said slide at said first position,another of said indicia being visible when said slide member is in saidsecond position to enable the user to confirm the location of said slideat said second position.
 9. The needle guide device of claim 4, whereinsaid barrel member comprises a cylindrical cavity having a longitudinalcentral axis and wherein said needle holder comprises an elongatedcylindrical member located within said cylindrical cavity and rotatableabout said longitudinal central axis, said needle holder having apassageway extending therethrough parallel to said longitudinal centralaxis, said passageway being configured for receipt of the needle thereinto establish the needle's trajectory.
 10. A needle guide device,comprising: a lockable mounting assembly configured for coupling to animaging transducer; and a needle guide assembly coupled to the lockablemounting assembly to retain a needle at a desired trajectory withrespect to the imaging transducer, wherein the needle guide assembly,comprises: a body member, a needle holder subassembly, and a slidemember, wherein said needle holder subassembly comprises: a barrelmember, and a needle holder, said needle holder being located in saidbarrel member, said barrel member being pivotably mounted on said bodymember, wherein said slide member is slidable with respect to said bodymember, in a plane parallel to a plane of the body member, and isfurther coupled to said barrel member to pivot said barrel member withrespect to said body member to a first angular orientation when saidslide member is slid to a first position, and to pivot said barrelportion with respect to said body member to a second angular orientationwhen said slide member is slid to a second position, wherein said barrelmember comprises a cylindrical cavity having a longitudinal central axisand wherein said needle holder comprises an elongated cylindrical memberlocated within said cylindrical cavity and rotatable about saidlongitudinal central axis, said needle holder having a passagewayextending therethrough parallel to said longitudinal central axis, andsaid passageway being configured for receipt of the needle therein toestablish the needle's trajectory, wherein said barrel member includes aslot in communication with said cylindrical cavity and extendingparallel and to said longitudinal central axis and wherein said needleholder comprises a slot in communication with said passageway, saidneedle holder being rotatable within said cylindrical cavity between aclosed and open position and vice versa, said slot in said needle holderbeing aligned with said slot in said barrel ember when said needleholder is rotated to said open position wherein a needle extendingthrough said passageway can be removed from said needle holder laterallythrough said aligned slots and a needle can be introduced into saidpassageway laterally through said aligned slots, said slots beingunaligned when said needle holder is in said closed position, whereupona needle disposed in said passageway is held therein.